MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE068KIT
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following device codes also apply to this complaint: (b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace 68) was fractured approximately 64.0 cm from the hub and ovalized approximately 105.0 and 115.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured and ovalized.This type of damage typically occurs due to improper handling during removal from the packaging.If an attempt is made to withdraw the ace 68 from the packaging shell prior to removing the tubing tray, damage such as this may occur.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure, the physician noticed that the penumbra system ace 68 reperfusion catheter (ace 68) was fractured at the mid-shaft and its inner core was unraveled and stretched upon removal from the packaging of the penumbra system ace 68 hi-flow kit (kit).The damaged ace 68 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new penumbra system ace 64 reperfusion catheter.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6121990
• Report Number: 3005168196-2016-01671
• Device Sequence Number: 10959219
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1